Cannabidiol for Postoperative Opioid Reduction in Primary Total Knee Arthroplasty
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorChad Brummett
About this trial
The goal of this study is to better understand how daily treatment with cannabidiol (CBD) affects the need for opioid pain medication, as well as pain, inflammation and other related symptoms, after knee replacement surgery. The information collected in this study is necessary to help understand whether CBD may be a useful medication before and/or after surgery.
The study hypothesis is that CBD exerts opioid-sparing effects through anti-inflammatory, analgesic, and anxiolytic mechanisms.
Eligibility criteria
Qualifiers
Willing and able to read, understand, and sign the informed consent (English)
Willingness to participate in all study measures and restrictions, including patient-reported outcomes and longitudinal follow-up
Scheduled for surgery: primary total knee arthroplasty
Primary diagnosis of osteoarthritis of the surgical knee
Disqualifiers
Revision or bilateral total knee arthroplasty
Individuals receiving or actively applying for worker's compensation or disability and other aspects associated with potential secondary gain (postoperative disability for recovery is permitted)
Severe physical impairment or clinically significant illness (e.g., blindness, paraplegia)
Co-morbid medical conditions that may significantly impair physical functional status (e.g., current non-skin malignancies, solid organ transplant in the past year)
Trial design
Treatments tested in this trial
- Epidiolex oral solution
- Placebo
Treatment groups
380 Participants
are divided into 4 treatment groupsSponsors and collaborators
Chad Brummett
Lead sponsor
University of Michigan
Sponsor institution
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborator
Source ClinicalTrials.gov